Field of the Invention
The present invention relates to methods and systems for managing the ordering, approving, and filling of biotech/specialty drug prescriptions electronically. In particular, this invention relates to methods and systems in which healthcare providers submit prior authorization requests to health plans, obtain necessary approval per the health plan's approval criteria, and submit medically-coded drug orders to specialty pharmacies, all within a web-enabled platform.
Related Art
Pharmaceuticals come in oral, injected, inhaled, or infused versions. Generally speaking, drugs that are orally ingested or are self-administered are covered under the patients' pharmacy benefit with their respective health insurance plans. Pharmacy Benefit Managers (PBM) prospectively administer each prescription using a drug's National Drug Code (NDC). Every pharmaceutical has an assigned NDC code which describes the package size (number of pills per package) and medication dosages (i.e. mg/pill). While the vast majority of prescriptions are supplied to patients under their pharmacy benefits (approximately 80%), medically coded drugs that require professional administration (i.e. infused, injected, or specific oral medications) are adjudicated as part of a patient's medical benefit portion of their health insurance coverage.
These medically coded medications that fall under the medical benefit tend to be biotech/specialty medications. The “specialty” term as used herein may refer to a drug (“specialty drug” or “specialty medication”) or to a pharmacy (“specialty pharmacy”). Specialty drugs are usually made by a biotech manufacturing process, and specialty pharmacies store and dispense these drugs in a manner appropriate for such biotech medications. Generally, a biotech manufacturing process refers to any manufacturing process for the production of medications that have a “biologic” or “protein-based” chemical make-up. These types of medications require injections or infusions rather than being orally ingested as well as special handling/refrigeration, and exhibit toxicities and side-effects which typically necessitate clinical oversight during the course of the prescribed therapy. Drugs produced by biotech manufacturing processes are used to treat a variety of diseases, including cancer.
These specialty drugs require professional administration and/or clinical oversight due to their particular characteristics. Therefore, these medically coded medications are billed manually on the same claim forms that are used for medical procedures, such as the HCFA-1500 or CMS-1500. Medical benefit procedural codes include J, S, and R codes that are used to bill for a drug or other biological that is administered to the patient by a physician (or a properly trained and supervised physician assistant or nurse in the healthcare/medical service provider's office/practice). An example of a current claim form for medical diagnoses, procedures and products, including medically-coded drugs, is shown in FIG. 12. The NDC code is rarely included on the HCFA-1500 form. Currently, HCFA 1500 and CMS 1500 forms do not capture a drug's NDC number to identify vial size, vial strength, or brand of medication dispensed. Manual auditing processes using these forms have been used to capture NDC number dispensed. Accordingly, all of the current processes for using these forms are retrospective (i.e., after the physician has performed the procedure and administered the drug to the patient), and there are no automated prospective systems or processes in place for concurrently verifying patient's eligibility for the drug, controlling the amount of drug that is used, steering to the optimal setting of care, and for controlling duration of therapy before the procedure takes place.
The healthcare providers must continue to use the manual systems and processes for their billing of the medically-coded drugs because, prior to this invention, none of the current systems, including the electronic platforms offered by the PBMs, have appreciated that an integrated system is necessary to automate the process. Specifically, an automated system for ordering medically-coded drugs should have an integrated knowledge-base system that can prospectively evaluate the health plan's requirements for prior authorizations of the drugs, preferably in an adaptive and interactive manner, as well as provide a feedback loop which tracks the corresponding drugs that the healthcare providers ordered from the specialty pharmacies and ultimately administered to the patients. The current PBM systems are not satisfactory for handling medically-coded drugs because the process for pharmacy-benefit drugs is linear, and the systems do not have a feedback loop that is integrated between the services provided by the healthcare provider and drugs dispensed by the pharmacy. Additionally, PBMs can only accept orders from a pharmacy holding a licensed and unique pharmacy provider code. Medically-coded drugs originate in the doctor's office, which cannot access PBM systems.
In the typical situation in which a drug is covered under the patient's pharmacy benefit plan, a treating physician examines the patient, renders a diagnosis and prescribes a drug. The patient (or physician/healthcare provider) chooses a pharmacy and upon receipt, the pharmacy dispenses the drug to the physician's practice or to the patient for administration. The physician's medical office bills the health plan for the medical procedure, and any feedback loop on the services between the medical office and the health plan, including the authorization for the services and ultimate payment thereon, is performed entirely apart from the pharmacy's dispensing of the drugs. In fact, the entire process between the physician and the health plan is completely unrelated to any interaction that may follow between the patient's pharmacy and health plan. Whether or not the patient fills the prescription with the pharmacy has no bearing on whether the healthcare provider will get paid because any authorization from the health plan for the medical services provided are wholly unrelated to the drugs that are prescribed and then dispensed by a pharmacy as the pharmacy-benefit drugs are covered under the pharmacy benefit plan. Therefore, the systems that are used to manage the process between a medical office and its patients' health plans are devoid of any feedback from or integrated with information from the patients' pharmacies.
Similarly, the subsequent process between the patient and the pharmacy, including authorizations from the health plan for coverage of the pharmacy-benefit drugs and subsequent payment, is wholly unrelated to the authorization and payment for the medical services. Whether or not a pharmacy is paid by a health plan for a drug it dispenses is wholly unrelated to any payments a medical office may receive for the medical tests a physician performed on the patient in order to render a diagnosis and prescribe the appropriate drug. Accordingly, the current systems developed for PBM processes are focused on the interaction between the patient and the pharmacy and do not provide for much integration between the pharmacy and the healthcare provider.
Due to the lack of integration, functionality, and feedback in the current systems that are used to manage pharmacy benefit plans, current systems are unable to automate the authorization and approval process for medically-coded drugs. Additionally, the current PBM systems fail to incorporate a knowledge-base that should be used to speed the processing of requests for authorization approvals so that the requests can be performed using adaptive and interactive processes, in real-time. None of the current systems are sufficiently integrated to permit the interactive sharing of information between health plans, healthcare providers and specialty pharmacies to permit the feedback necessary to track medically-coded drugs that healthcare providers order from specialty pharmacies and ultimately administer to their patients in their offices. Lastly, current systems cannot accept electronic requests from the physician's practice, which is where an order for a medically-coded drug would originate.
While less than 20% of drug claims are billed as part of the medical benefit portion of a patient's health insurance, the medications in this category are typically very expensive. In general, a monthly oral prescription averages $50 per prescription, while a monthly medically-coded drug averages $1500 per prescription. Additionally, approximately 45%-50% of the drugs in the near-term pharmaceutical pipeline are likely to be medically-coded drugs. Given these facts, and without the solutions offered by the process and system of the present invention, it is understandably why health plans have increasing concern over ways to control the costs of medically coded drugs. The concern is shared by all payers, including health insurance companies, governmental health plans, and employers.
Medications billed to a medical benefit have National Drug Codes (NDC), but they are difficult to capture and quantify as the primary claim form, the HCFA-1500, cannot accept NDC-level coding. For example, a health plan may approve the use of the biotech drug REMICADE® under the current manual processes. However, under the current process, the plan does not know what dosage of REMICADE® is used or how often it is infused when the approval is given. The REMICADE® drug is dispensed in liquid form for infusion based on patient weight and dose/kg needed for that patient. Even though REMICADE® has an assigned NDC, the current processes require that a J-code be identified to approve REMICADE® for the treatment (instead of the NDC) because a health plan will not know what dose of the drug is dispensed until after the specialty pharmacy has provided the drug to the patient and/or physician. In general, health plans do not know what package size or dosage of medication is requested or dispensed when a medication is billed to the medical benefit. This creates difficulty for payers to implement appropriate utilization management tools to control wastage, inappropriate utilization, and avoidable costs associated with medications dispensed and administered under a patient's medical benefit.
Operationally, health plans lack prospective controls to manage costs associated with medically coded drugs billed as procedural J, R, or S codes. As procedural codes they do not identify drug utilization at the NDC level. Even after an authorization is approved for a medical drug regimen, the cost for that transaction can vary greatly and will not become evident until the claim is submitted. As claims are typically submitted 45-60 days after the date of service, payers can do very little to ensure optimal utilization and cost. Therefore, there is no prospective cost containment on the medically-coded drugs, only a retrospective evaluation based on a formal audit. Instead, what is truly needed is a prospective electronic authorization system which can account for the eligibility status of the patient and to adaptively guide a user to enter patient specific criteria, health plan specific criteria, drug specific criteria, site of drug administration, and select a pharmacy to dispense the medically coded drug. Other needs of the health plan are listed below.
As used herein, health plan generally refers to any entity that owns the “risk” for the medical care provided to its members. The health plan term can be used synonymously with “payer” or “health insurer”. Health Plans typically require an approval process for procedures and medications deemed to be high-cost or otherwise having the potential to be mismanaged. Biotech/specialty drugs usually require prior authorization, and when such a procedure or medication is required, the physician or other healthcare service provider contacts the Health Plan via telephone or fax to obtain an approval. Using traditional systems that are currently in place, an approval typically takes 24-72 hours to obtain, and requires the transmittal of clinical and financial information. As it will become apparent from the description of the invention provided herein, the inventive system reduces this approval time period from days to minutes. Once approved, the prescription and approval are submitted to a pharmacy for dispensation, and the delivery of the medication is coordinated with the physician and/or the patient for injection/infusion.
A Pharmacy Benefit Manager (PBM) is a service provider that uses a computer database to manage the utilization of common prescription drugs. Requests for common drugs originate at the retail pharmacy, and the PBM electronically verifies the patient's insurance coverage for the drug, and imposes a tiered out-of-pocket cost structure based on the drug that is ordered. PBMs also reimburse the pharmacy for the drugs that are dispensed using a NCPDP claim form. The vast majority of PBM transactions, including reimbursements, are conducted electronically.
Every pharmaceutical approved for sale in the USA has a specific National Drug Code (NDC). The NDCs are typically 11 digits long, and define drug, manufacturer, vial size, and strength. PBM transactions use the NDC for drug management and reimbursement. However, for the reasons provided above, medically coded drugs do not follow typical PBM adjudication because they require professional oversight, and requests for these drugs originate in a medical practice or clinic. The medically coded drugs are those medications that are often infused or injected that are paid from a patient's medical benefit portion of their health insurance coverage. As also explained above, the HCFA 1500/CMS 1500 forms are typically used by healthcare/medical service providers to bill claims to Health Plans for procedures and/or medications. Biotech medications are typically billed using these forms to charge a blended rate for the drug and the infusion/injection procedure. HCFA-1500 forms do not have the ability to capture the NDC for the drug that is administered, nor can these forms be accepted by a PBM. The medical benefit procedural codes (J, S, R-Codes) are the procedural codes used on the HCFA-1500 claim forms by healthcare/medical service providers to garner reimbursements for administering biotech/specialty medications. J-codes are blended codes, including the cost of the drug and the cost to administer the drug.
For the reasons described above, the present systems and processes that are currently in place for medically coded drugs need to be improved for healthcare service providers, health plans and pharmaceutical manufacturers.
The needs of the health plan stakeholders are described above and are also summarized in the Health Plan Needs table below.